A monitoring system for a surgical instrument is provided. The surgical instrument includes a magnetic element and being configured to be subjected to a temperature-based sterilization process. The monitoring system includes a sensor configured to detect a magnetism parameter of the magnetic element. The monitoring system includes a controller in communication with the sensor. The controller is configured to evaluate the magnetism parameter, and based on the evaluation, generate an output indicative of usage of the surgical instrument.
Legal claims defining the scope of protection, as filed with the USPTO.
. A monitoring system for a surgical instrument, the surgical instrument comprising a magnetic element and being configured to be subjected to a temperature-based sterilization process, the monitoring system comprising:
. The monitoring system of, wherein the output indicative of usage of the surgical instrument is configured for indicating an end-of-life of the surgical instrument.
. The monitoring system of, wherein the output indicative of usage of the surgical instrument is configured for indicating:
. The monitoring system of, further comprising the controller configured to evaluate the magnetism parameter by comparing the magnetism parameter relative to a threshold.
. The monitoring system of, wherein the threshold is selected based upon a predictable degradation of the magnetism parameter per cycle of the sterilization process.
. The monitoring system of, wherein the predictable degradation is based on an effect upon the magnetic element due to an autoclave sterilization process.
. The monitoring system of, wherein the controller compares the magnetism parameter to the threshold by comparing the magnetism parameter to:
. The monitoring system of, wherein the magnetism parameter is one or both of a magnetic field density or a magnetic flux.
. The monitoring system of, wherein the magnetic element includes samarium cobalt.
. The monitoring system of, wherein the magnetic element includes a neodymium (NdFeB) magnet.
. The monitoring system of, wherein the sensor is disposed within an end effector of a surgical device that is configured to receive the surgical instrument.
. The monitoring system of, wherein the sensor is a magnetometer.
. A surgical system comprising:
. The surgical system of, wherein the surgical accessory is a cutting instrument or a burr guard for the cutting instrument.
. The surgical system of, wherein the output indicative of usage of the surgical accessory is configured for indicating an end-of-life of the surgical accessory.
. The surgical system of, wherein the output indicative of usage of the surgical accessory is configured for indicating how many uses to which the surgical accessory has been subjected.
. The surgical system of, wherein the output indicative of usage of the surgical accessory is configured for indicating how much useful life the surgical accessory has left.
. The surgical system of, wherein the sensor is disposed within an end effector of the surgical device that is configured to receive the surgical accessory.
. A method to generate an output to indicate usage of a surgical instrument, the surgical instrument including a magnetic element and being configured to be repeatedly subjected to a temperature-based sterilization process, the method comprising:
. The method of, further comprising:
Complete technical specification and implementation details from the patent document.
The subject patent application claims priority to and all the benefits of U.S. Provisional Patent Application No. 63/571,207, filed on Mar. 28, 2024, the entire contents of each are hereby incorporated by reference.
Before or during a surgical procedure, certain surgical instruments are sterilized or in a sterile state. During the course of a surgical procedure, the surgical instrument is exposed to body parts, tissue, blood, and the pathogens that are associated with such exposure. Some surgical instruments may be reused after a sterilization process. One example sterilization process includes placing the surgical instruments within an autoclave, wherein the surgical instruments are exposed to high temperature in order to sterilize the surgical instruments for use in a subsequent surgical procedure.
Instruments often experience wear and tear due to surgical usage and exposure to sterilization. Therefore, it is often desired to monitor how much usable life the instrument has left. Monitoring instrument usage can be a complicated and costly undertaking. Often such instruments are equipped with specialized chips or processors which communicate usage information to the main host device. However, such devices are costly and not suitable to endure high-temperature sterilization. Moreover, the usage of such conventional devices is monitored as a result of installation between the instrument and its host device. Prior techniques fail to provide a robust, consistent, and durable manner of monitoring usage of the instrument as a function of how many sterilization cycles the instrument has undergone.
This Summary introduces a selection of concepts in a simplified form that are further described in the Detailed Description below. This Summary is not intended to limit the scope of the claimed subject matter nor identify key features or essential features of the claimed subject matter.
According to a first aspect, a monitoring system for a surgical instrument is provided. The surgical instrument includes a magnetic element and being configured to be subjected to a temperature-based sterilization process. The monitoring system includes a sensor configured to detect a magnetism parameter of the magnetic element. The monitoring system includes a controller in communication with the sensor. The controller is configured to evaluate the magnetism parameter, and based on the comparison, generate an output indicative of usage of the surgical instrument.
According to a second aspect, a surgical system is provided. The surgical system includes a surgical accessory comprising a magnetic element. The surgical accessory is configured to be subjected to a temperature-based sterilization process. The surgical system further includes a surgical device configured to receive the surgical accessory. The surgical device comprises a controller and a sensor. The controller is configured to detect, with the sensor, a magnetism parameter of the magnetic element, evaluate the magnetism parameter, and based on the evaluation, generate an output to indicate usage of the surgical accessory.
According to a third aspect, a surgical device is provided. The surgical device includes a magnetic element configured to be subjected to a temperature-based sterilization process and a monitoring system comprising a sensor. The monitoring system is configured to detect, with the sensor, a magnetism parameter of the magnetic element, evaluate the magnetism parameter, and based on the evaluation, generate an output to indicate usage of the surgical device.
According to a fourth aspect, a surgical instrument configured to be repeatedly subjected to cycles of a sterilization process is provided. The surgical instrument includes a body and a magnetic element coupled to the body and configured to exhibit a magnetic field. The magnetic field degrades a predictable amount for each cycle of the sterilization process.
According to a fifth aspect, a method to generate an output to indicate usage of a surgical instrument is provided. The surgical instrument includes a magnetic element and being configured to be repeatedly subjected to a temperature-based sterilization process. The method includes utilizing a sensor to detect a magnetism parameter of the magnetic element. The method further includes, within a computerized processor, comparing the magnetism parameter to a threshold, and based upon the comparison, generating the output to indicate usage of the surgical instrument. The method may further include iteratively subjecting the surgical instrument to the temperature-based sterilization process, iteratively utilizing the sensor to detect the magnetism parameter, iteratively comparing the magnetism parameter to the threshold, and generating the output in response to identifying that the magnetism parameter has degraded past the threshold.
Any of the above aspects can be combined, in whole or in part.
Any of the above aspects can be combined, in whole or in part, with any of the following implementations:
The output indicative of usage of the surgical instrument may be configured for indicating an end-of-life of the surgical instrument. The output indicative of usage of the surgical instrument may be configured for indicating how many uses to which the instrument has been subjected. The output indicative of usage of the surgical instrument may be configured for indicating how much useful life the instrument has left.
The threshold may be selected based upon predictable degradation of the magnetism parameter per cycle of the sterilization process. The predictable degradation is based upon an autoclave sterilization process.
The magnetism parameter may be one or both of a magnetic field density or a magnetic flux.
The controller may compare the magnetism parameter to the threshold by being configured to determine an absolute measured flux value from the magnetism parameter and compare the absolute measured flux value to the threshold. The controller may compare the magnetism parameter to the threshold by being configured to determine a relative measured flux value from the magnetism parameter and compare the relative measured flux value to the threshold defined as a reference flux value.
The magnetic element may include a permanent magnet. The magnetic element may include samarium cobalt, a material that exhibits excellent predictable degradation after repeated exposure to high temperature cycles. The magnetic element may include a neodymium (NdFeB) magnet, another material that exhibits excellent predictable degradation after repeated exposure to high temperature cycles.
The sensor may be disposed within an end effector of a surgical device that is configured to receive the surgical instrument. The sensor may be a magnetometer.
The surgical accessory may be a cutting instrument or a burr guard for the cutting instrument.
Other features and advantages of the implementations of the present disclosure will be readily appreciated, as the same becomes better understood, after reading the subsequent description taken in conjunction with the accompanying drawings.
It will be appreciated that one or more of the implementations depicted throughout the drawings may have certain components, structural features, and/or assemblies removed, depicted schematically, and/or shown in phantom for illustrative purposes.
Referring to, a systemis provided. The systemcan be a surgical systemadapted for treating a patient. The surgical systemis shown in a surgical setting such as an operating room of a medical facility. The surgical systemmay be used to perform any intraoperative surgical procedure on a patient. Example surgical procedures include, but are not limited to: partial knee arthroplasty, total knee arthroplasty, total hip arthroplasty, shoulder arthroplasty, spinal procedures, ankle procedures, endoscopic procedures, cranial procedures, lesion removal procedures, arthroscopic procedures, arthroscopic resection procedures, soft tissue or ligament repair procedures, neurological procedures, ENT procedures, minimally invasive MIS procedures, or the like. In the example shown in, the patient is undergoing a knee procedure. In addition, the following implementations describe the use of the surgical systemin performing a procedure in which material is removed from a femur F and/or a tibia T of a patient. However, it should be recognized that the surgical systemmay be used to perform any suitable procedure in which material is removed from any suitable portion of a patient's anatomy, material is added to any suitable portion of the patient's anatomy (e.g., an implant, graft, etc.), and/or in which any other control of and/or visualization of a surgical instrument is desired.
The systemmay include a robotic manipulator. In the example shown, the robotic manipulatorhas a baseand plurality of links. A manipulator cartsupports the robotic manipulatorsuch that the robotic manipulatoris fixed to the manipulator cart. The linkscollectively form one or more arms of the robotic manipulator. The robotic manipulatormay have a serial arm configuration (as shown in) or a parallel arm configuration. In other examples, more than one robotic manipulatormay be utilized in a multiple arm configuration. The robotic manipulatormay comprise a plurality of (prismatic and/or rotating) joints J and a plurality of motor and/or joint encoderslocated at the joints J for determining position data of the joints J. For simplicity, only one joint encoderis illustrated in, although it is to be appreciated that the other joint encodersmay be similarly illustrated. The robotic manipulatoraccording to one example has six joints J-Jimplementing at least six-degrees of freedom (DOF) for the robotic manipulator. The robotic manipulatormay have any number of degrees of freedom and may have any suitable number of joints J and redundant joints J.
Numerous examples of surgical instruments(“instrument”) will now be described. The instrumentcan include any surgical instrument utilized in the operating room. The instrumentcan be coupled to the manipulator, can be freely held in-hand, or part of any other equipment in the operating room. The instrumentcan be a surgical device, a surgical accessory, a surgical component, or any combinationor sub-combination of components. The instrumentmay be said to be aligned with instrument axis R. Examples of the instrumentinclude, but are not limited to: an end effector, a cutting tool (e.g., saw blade, cutting bur, router, reamer) that inserts into the end effector, a tool guard, a pointer P or probe, a retractor, a handheld robotic device, a cutting tool that installs to the handheld device, a navigation tracker, a mounting device (e.g., clamp, bone plate, coupling) that attaches a component to bone, a surgical implant, screws or fasteners, forceps or scissors, and the like. The instrumentcan be any instrument that is subjected to sterilization and used in any of the described surgical procedures.
The surgical instrumentmay couple to the robotic manipulatorand be movable relative to the baseto interact with the anatomy in certain modes. The instrumentis or can form part of an end effector. The instrumentmay be grasped by the operator. One example arrangement of the robotic manipulatorand the instrumentis described in U.S. Pat. No. 9,119,655, filed on Aug. 2, 2013, entitled, “Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes,” the disclosure of which is hereby incorporated by reference. The robotic manipulatorand the instrumentmay be arranged in alternative configurations. The instrumentcan be like that shown in U.S. Pat. No. 9,566,121, filed on Mar. 15, 2014, entitled, “End Effector of a Surgical Robotic Manipulator,” hereby incorporated by reference.
In some examples, the robotic manipulatorcan be a handheld manipulator with a base portion (e.g., a portion held free-hand by the user against the force of gravity) and a moveable portion that moves relative to the base portion by actuators. The instrumentcan be coupled to the moveable portion. Such a handheld manipulator can be like that shown in U.S. Pat. No. 9,707,043, filed on Aug. 31, 2012, entitled, “Surgical Instrument Including Housing, A Cutting Accessory that Extends from the Housing and Actuators that Establish the Position of the Cutting Accessory Relative to the Housing,” and in PCT application No. PCT/US2020/042128, entitled “Robotic Hand-Held Surgical Instrument Systems and Methods,” filed on Jul. 15, 2020, the entire contents of both of which are hereby incorporated by reference.
The instrumentmay include an energy applicatordesigned to contact the target site, such as the tissue of a patientat the surgical site. The energy applicatormay be a rotary cutting bur, drill, saw blade, impactor, reamer, router, ultrasonic vibrating tip, or the like.
The systemmay include a robot system controller. The robot system controllerincludes software and/or hardware for controlling the robotic manipulator. The robot system controllerdirects the motion of the robotic manipulatorand controls a state (position and/or orientation) of the instrumentwith respect to a coordinate system of the manipulator.
As shown in, the systemmay further include a navigation system. One example of the navigation systemis described in U.S. Pat. No. 9,008,757, filed on Sep. 24, 2013, entitled, “Navigation System Including Optical and Non-Optical Sensors,” hereby incorporated by reference. The navigation systemis configured to track movement of various objects. Such objects include, for example, the robotic manipulator, the instrumentand the anatomy, e.g., femur F and tibia T. The navigation systemtracks these objects to gather state information of each object with respect to a (navigation) localizer coordinate system LCLZ. Coordinates in the localizer coordinate system LCLZ may be transformed to a manipulator coordinate system MNPL, and/or vice-versa, using transformation techniques described herein.
The navigation systemmay include a cart assemblythat houses a navigation computer, and/or other types of control units. A navigation interface is in operative communication with the navigation computer. The navigation interface includes one or more displays. First and second input devices,may be used to input information into the navigation computeror otherwise to select/control certain aspects of the navigation computer. As shown in, such input devices,include interactive touchscreen displays. The input devices,may include any one or more of a keyboard, a mouse, a microphone (voice-activation), gesture control devices, and the like. The robot system controllermay be implemented on any suitable device or devices in the system, including, but not limited to, a manipulator computer, the navigation computer, and any combination thereof. The navigation systemalso includes a navigation localizer(hereinafter “localizer”) coupled to the navigation computer. In one example, the localizeris an optical localizer and includes a camera unit. The camera unithas an outer casingthat houses one or more optical sensors.
The navigation systemmay include one or more trackers. In one example, the trackers include a pointer tracker PT, one or more manipulator trackers(e.g.,A,B), a first patient tracker, and a second patient tracker. In the illustrated example of, the manipulator trackeris attached to the instrument(i.e., trackerA), the first patient trackeris firmly affixed to the femur F of the patient, and the second patient trackeris firmly affixed to the tibia T of the patient. In this example, the patient trackers,are firmly affixed to sections of bone. The pointer tracker PT is firmly affixed to a pointer P used for registering the anatomy to the localizer coordinate system LCLZ. The manipulator trackermay be affixed to any suitable component of the robotic manipulator, in addition to, or other than the instrument, such as the base(i.e., trackerB), or any one or more linksof the robotic manipulator. The trackers,,, PT may be fixed to their respective components in any suitable manner. Any one or more of the trackers may include active markers. The active markersmay include light emitting diodes (LEDs). Alternatively, the trackers,,may have passive markers, such as reflectors, which reflect light emitted from the camera unit. Other suitable markers not specifically described herein may be utilized. The localizertracks the trackers,,to determine a state of each of the trackers,,, which correspond to the state of the object respectively attached thereto. The localizerprovides the state of the trackers,,to the navigation computer. In one example, the navigation computerdetermines and communicates the state the trackers,,to the manipulator computer. As used herein, the state of an object includes, but is not limited to, data that defines the position and/or orientation of the tracked object or equivalents/derivatives of the position and/or orientation. For example, the state may be a pose of the object, and may include linear data, and/or angular velocity data, and the like.
Although one example of the navigation systemis shown in the Figures, the navigation systemmay have any other suitable configuration for tracking the robotic manipulatorand the patient. In one example, the navigation systemand/or localizerare ultrasound-based. In another example, the navigation systemand/or localizerare radio frequency (RF)-based. The navigation systemand/or localizermay have any other suitable components or structure not specifically recited herein. Furthermore, any of the techniques, methods, and/or components described above with respect to the camera-based navigation systemshown throughout the Figures may be implemented or provided for any of the other examples of the navigation systemdescribed herein. For example, the navigation systemmay utilize solely inertial tracking or any combination of tracking techniques.
The robot system controllerfurther includes software modules. The software modules may be part of a computer program or programs that operate on the manipulator computer, navigation computer, or a combination thereof, to process data to assist with control of the system. The software modules include instructions stored in memory on the manipulator computer, navigation computer, or a combination thereof, to be executed by one or more processors of the computers,. Additionally, software modules for prompting and/or communicating with the operator may form part of the program or programs and may include instructions stored in memory on the manipulator computer, navigation computer, or a combination thereof. The operator interacts with the first and second input devices,and the one or more displaysto communicate with the software modules. The user interface software may run on a separate device from the manipulator computerand navigation computer.
The robot system controllerincludes a manipulator controllerfor processing data to direct motion of the robotic manipulator. In one example, as shown in, the manipulator controller is implemented on the manipulator computer. The manipulator controllermay receive and process data from a single source or multiple sources. The robot system controllerfurther includes a navigation controllerfor communicating the state data relating to the femur F, tibia T, and robotic manipulatorto the manipulator controller. The manipulator controllerreceives and processes the state data provided by the navigation controllerto direct movement of the robotic manipulator. In one example, as shown in, the navigation controlleris implemented on the navigation computer. The manipulator controlleror navigation controllermay also communicate states of the patientand robotic manipulatorto the operator by displaying an image of the femur F and/or tibia T and the robotic manipulatoron the one or more displays. The manipulator computeror navigation computermay also command display of instructions or request information using the displayto interact with the operator and for directing the robotic manipulator.
The surgical instrumentmay be described as an instrument or an end effector capable of or configured for being utilized by a surgeon manually or semi-manually. An alternative robotic system is shown generally atin. In one example, the robotic systemhas a base, an arm, and semi-manually operable instrument. The instrumentincludes an internal motor, a trigger actuator, and an instrument accessory. The instrumentmay be connected to the armwith a separable connection. The instrumentis semi-manual in so far as the robotic systemmay still guide movement of the instrument, constrain movement of the instrument, or otherwise provide moderated or partially controlled operation of the instrument. The baseis mobile allowing transportation to different operating rooms, as necessary. The armis a robotic arm and is moveably attached to the base. The armmay assist the user during a surgical procedure by supporting and aligning an end effector. The armmay reduce user fatigue and error by supporting the end effector while in use, as well as restricting movement that is outside of a predetermined range. One such arm is disclosed in U.S. Pat. No. 8,010,180, filed on Feb. 21, 2006, entitled “Haptic Guidance System and Method,” the disclosure of which is hereby incorporated herein by reference.
An implementation of an instrumentis schematically illustrated in. The instrumentmay be utilized in the robotic systemof, wherein the instrumentmay be operable with and supported by the arm. Alternatively, the instrumentmay be handheld such that the instrumentis supported by a hand and arm of the user. The instrumentis illustrated including the triggeruseful for manual operation of the instrumentand the motorconfigured for providing an output power to provide energy to the instrument accessory. A position of triggermay be biased by a spring feature. The instrumentis illustrated including a receiverthrough which instrument accessoryis inserted. The receivermay be described as a collet, a chuck, or other similar structure. The instrument accessoryis illustrated including a permanent magnetaffixed to or formed within a shaft of the instrument accessory. The instrumentincludes a corresponding magnetic signature sensorpositioned within the instrument. The magnetic signature sensormay be utilized to determine a presence of or an identity of the instrument accessory, for example, with the instrumentconditionally being enabled for operation based upon a signal from the magnetic signature sensorconfirming that the correct instrument accessoryis installed to the instrument. Further, the triggeris illustrated including a permanent magnet. The instrumentis equipped with at least two sensors,configured to monitor proximity of and/or a position of the permanent magnetrelative to the sensors,.
illustrates an alternative implementation of an instrument, which may be mounted upon the robotic manipulatorof. The instrumentis illustrated including an instrument accessoryincluding a cutting burrwhich may be utilized in a surgical procedure. Another instrument accessory can be a burr guardsurrounding a portion of the spinning shaft of the instrument accessoryand configured to prevent human contact to the portion of the spinning shaft.
illustrates the burr guardand the instrument accessoryof. The burr guardis illustrated in a side sectional view. The instrument accessoryis illustrated including the burr end, a shaft or body, and a magnetic element embodied as a first permanent magnetdisposed within the body. The burr guardis illustrated including lumenconfigured to receive the body, a sensorconfigured to monitor presence of the permanent magnetwhen the bodyis present within the lumen, and a second permanent magnet. An end effector portionis additionally illustrated including a sensorconfigured to monitor a presence of the second permanent magnet. The second permanent magnetmay be used to confirm presence of the burr guardrelative to the instrumentof.
While the description and figures above provide certain examples of surgical instruments and instrument accessories, the techniques described herein can be utilized with any type of instrument or instrument accessories.
Described herein are various implementations of monitoring systems, surgical devices, surgical instruments, methods, and non-transitory computer readable medium comprising instructions and techniques for monitoring usage of a surgical instrument or accessory. The described techniques involve a magnetic clement to be subjected to a temperature-based sterilization process and a sensor to detect a magnetism parameter of the magnetic element. The magnetism parameter is evaluated to generate an output indicative of usage of the surgical instrument/accessory.
The surgical instrument or accessory,,,,,may each or both include a permanent magnet. Permanent magnets and sensors configured to monitor presence and properties of the magnets may be utilized in medical and surgical instruments for a number of purposes. In one implementation, the surgical instrument may include a magnetometer sensor and a magnet configured to interact with the magnetometer sensor, for example, to measure presence, identity, movement, or rotational velocity of the magnet in relation to the magnetometer sensor. A magnet may include a permanent magnet or a ferrous component that has been magnetized. A permanent magnet loses magnetism slowly over time, for example, through temperature fluctuations, presence of stray magnetic fields, and mechanical shocks, impacts, or movement. A permanent magnet may lose magnetism more rapidly if exposed to high temperatures. This loss of magnetism or this change in magnetic field properties related to a permanent magnet upon the surgical instrument or accessory,,,,,may be used as a gage or proxy to estimate usage of the surgical instrument or accessory,,,,,. The magnet may include a magnetic element including samarium cobalt or a neodymium (NdFEB) magnet.
In one implementation, the surgical instrument or accessory,,,,,may include a magnet useful to identify to the system,a presence and/or an identity and/or a configuration of the surgical instrument or accessory,,,,,. A sensor such as a magnetometer sensor or a Hall Effect sensor may be utilized by the system,to measure and indicate a presence of and a configuration of the magnet present upon the surgical instrument or accessory,,,,,.
The surgical instrument,,of, once used in a surgical procedure, may be re-used after a sterilization process is performed upon the device. Such a sterilization process may include an autoclave process, wherein the surgical instrument,,may be exposed to high temperatures and liquids configured to sterilize the surgical instrument,,. A surgical instrument may predictably age or deteriorate after each usage and/or each corresponding operation of a sterilization process upon the surgical instrument. Actions may be taken in response to a surgical instrument reaching a certain age or going through a quantifiable amount of usage. A surgical instrument may be reconditioned, a blade may be sharpened, a replacement part may be ordered, or the surgical instrument may be retired.
A magnet includes properties which may be measured, such as magnetic field intensity (B) and magnetic flux (Φ). The magnet may deteriorate over time as a result of exposure to heat during a sterilization process or when exposed to frictional heat, such as when used as part of a rotating device. The magnet may exhibit predictable, trackable, or repeatable degradation as a result of exposure to heat. An instrument, a system, and a method useful for generating an output to indicate usage of an instrument or the instrument are provided. By tracking degradation of a permanent magnet, correlated usage of the instrument may be estimated and provided as the output. The output to indicate usage of the surgical instrument may be an estimate or indication of an age, a portion of lifespan, or a measure of accumulated usage of the surgical instrument. Wherein methods to track surgical instrument usage may include manually tracking or database tallying of how many times the surgical instrument is installed within a device or signed into a surgical procedure, a disclosed instrument, system, and method to estimate surgical instrument accumulated usage or a measure of instrument lifespan duration is provided utilizing magnetic signature degradation. The surgical instrument may include one or more of a variety of surgical instruments described above, such as any surgical instrument or accessory,,,,,of.
schematically illustrates an example monitoring systemincluding a surgical instrumentincluding a magnetic elementconfigured to output an indicated usage of the surgical instrumentbased upon measuring a magnetic parameter of the permanent magnet, comparing the magnetism parameter to a threshold, and generating the output of indicated usage based upon the comparison. Throughout the disclosure, magnetic elementmay be construed to include a permanent magnet. The monitoring systemis illustrated including the surgical instrumentincluding magnetic element, a sensorconfigured to measure the magnetic parameter of the magnetic element, and a controllerconfigured to operate programming to evaluate measurements gathered by the sensor. The surgical instrumentmay be a one-piece device. The sensormay additionally be utilized in operation of the surgical instrument, for example, for confirming presence and/or identity of the surgical instrument, or the sensormay be specifically present for the purpose of taking measurements of a magnetic fieldcreated by the magnetic elementfor the purpose of the disclosure. Measurements taken by the sensorof the magnetic fieldgenerated by the magnetic elementmay be utilized, as described herein, for estimating an indicated usage of the surgical instrument.
The controllermay be a circuit board, an integrated circuit, or a computerized device including a processor, random-access memory (RAM), and durable storage memory. The term “memory” is intended to comprise memory associated with a processor such as a CPU, and may include, for example, RAM (random access memory), ROM (read only memory), a fixed memory device (for example, hard drive), a removable memory device (for example, diskette), a flash memory, combinations thereof, and the like. The controllerincludes programming configured to monitor measurements provided by the sensor, evaluate the measurements, and to estimate an indicated usage of the first portionor of the surgical instrumentbased upon the evaluation. The controllermay be a standalone electronic device, the controllermay be a part of a larger system controller or computerized unit, or the controllermay describe functionality spanning a plurality of physical devices. The controllercan receive sensor measurements using hard-wired or wireless communication. Hence, in some cases, the controllercan be remote from the surgical instrument.
The controllermay be connected to or configured to communicate with an output deviceconfigured to display or take action based upon an output of indicated usage provided by the controller. The output devicemay include one or more light emitting diode (LED) lights configured to emit a color of light based upon output of indicated usage provided by the controller, e.g., with green indicating early-lifespan period or conforming indicated usage, with yellow indicating indicated usage in a warning or mid-lifespan period, and with red indicating end-of lifespan or indicated time for refurbishment or replacement. The output devicemay emit a tone or a vibration, transmit data to a database, or provide another type of output useful to convey the output of indicated usage. The output devicemay be a display, such that when a user activates a scan of the surgical instrument, the output of indicated usage may be displayed to a user by text and/or graphic. In one example, a percentage of expected lifespan remaining may be displayed. In another example, a prompt asking the user to command ordering a replacement instrument may be presented. Such a command may be relayed to a local facility manager or directly to a medical device vendor. A visual display capable of displaying graphics may provide the output of indicated usage in a variety of ways, and the disclosure is not intended to be limited to the examples provided.
The implementation ofmay include, in one example, the instrument accessoryofwith the magnetic element, the sensor, the controller, and the output deviceeach disposed upon the instrument accessory. The output devicemay include circuitry to output data wirelessly to a remote computerized device or a remote server device, with the output data describing accumulated or historical usage of the instrument accessorybased upon monitored degradation of properties of the magnetic element.
schematically illustrates an alternative monitoring system′ including a surgical instrument′ including a magnetic elementconfigured to output an indicated usage of the surgical instrument′ based upon measuring a magnetic parameter of the permanent magnet, comparing the magnetism parameter to a threshold, and generating the output of indicated usage based upon the comparison. The monitoring system′ is illustrated including the surgical instrument′ including magnetic element. The surgical instrument′ further includes a sensorconfigured to measure the magnetic parameter of the magnetic element. The monitoring system′ further includes a controllerconfigured to operate programming to evaluate measurements gathered by the sensor. The surgical instrument′ may be a one-piece device. In the illustrated implementation of, the surgical instrument′ is illustrated including a first portionand a second portion. In the illustrated implementation, the permanent magnet is in the first portionand the sensoris in the second portion. The first portionand the second portionmay be separable, e.g., at parting line. In one example implementation, the surgical instrument′ may include the second portionembodied as a handheld trigger-grip instrument and the first portionembodied as an instrument end powered, turned, or otherwise controlled by the second portion. The sensormay additionally be utilized in operation of the surgical instrument, for example, for confirming presence and/or identity of the first portion, or the sensormay be specifically present for the purpose of taking measurements of a magnetic field created by the magnetic elementfor the purpose of the disclosure. Measurements taken by the sensorof the magnetic field generated by the magnetic elementmay be utilized, as described herein, for estimating an indicated usage of the first portionand/or of the surgical instrument′.
The controllerand the output deviceofmay be standalone devices, may be integrated together into a single device, or may be disposed within a larger electronic system, such as a robotic controller.
The implementation ofmay include the first portionembodied in one example as the instrument accessoryofwith the magnetic elementbeing disposed upon or within an instrument accessory. The sensormay be disposed upon a connecting instrument,,ofwhich communicates data from the sensorto the controller. The controllerand the output devicemay each be disposed upon equipment associated with a robot or controlling surgical monitoring system or may be disposed at a remote location, for example, with a remote server device operated by a hospital, a hospital system, or a surgical equipment monitoring company. The output devicemay include circuitry to output data visually, as data within a computer reporting program, and/or as procedure enabling/disabling protocols based upon a determined aggregated usage of the end first portion.
Unknown
October 2, 2025
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